EVOLUTION NitrX Medial-Pivot Knee

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line. May 16, 2019 MicroPort Orthopedics, Inc. Ryan Ross Manager, Regulatory Affairs 5677 Airline Road Arlington, Tennessee 38002 Re: K182251 Trade/Device Name: EVOLUTION® NitrX™ Medial-Pivot Knee Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: August 17, 2018 Received: August 20, 2018 Dear Ryan Ross: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, CAPT Raquel Peat, PhD, MPH, USPHS FOR Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) ### K182251 Device Name EVOLUTION® NitrX™ Medial-Pivot Knee #### Indications for Use (Describe) The EVOLUTION® NitrX™ Medial-Pivot Knee is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1. Non-inflammatory degenerative joint disease: including osteoarthritis, or avascular necrosis 2. Inflammatory degenerative joint disease, including rheumatoid arthritis; 3. Correction of functional deformity 4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ EVOLUTION® NitrX™ Medial-Pivot Knee Traditional 510(k) Image /page/3/Picture/3 description: The image is a logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red star-like shape. To the right of the square is the word "MicroPort" in blue, with the word "Orthopedics" in red underneath. MicroPort Orthop Arlington, TN ortho.microport.com # 510(k) Summary of Safety and Effectiveness In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the use of the EVOLUTION® NitrX™ Medial-Pivot Knee. | Submitted by: | MicroPort Orthopedics Inc.<br>5677 Airline Rd, Arlington TN, 38002<br>Phone: 866-872-0211<br>Fax: 855-446-2247 | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------| | Date: | May 16, 2019 | | Contact Person: | Ryan Ross<br>Manager, Regulatory Affairs | | Proprietary Name: | EVOLUTION® NitrX™ Medial-Pivot Knee | | Common Name: | Cemented Tibial Base<br>Cemented Femur | | Classification Name and Reference: | 21 CFR 888.3560 Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained cemented prosthesis<br>Class II | | Subject Product Code and Panel Code: | Orthopedics/87/JWH | | Predicate Device: | EVOLUTION® Medial Pivot Total Knee System (K093552,<br>K102380) | | Reference Device: | Foundation® Knee System with TiNbN Coating, Foundation® PS<br>Knee System with TiNbN Coating, 3DKnee™ System with TiNbN<br>Coating (K122239) | | Reference Device: | EVOLUTION® Knee Systems - MR Labeling (K180317) | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image is a logo for MicroPort Orthopedics. The logo features a blue square with rounded corners on the left side, inside of which is a white circle containing a red diamond shape. To the right of the square is the word "MicroPort" in blue, with the word "Orthopedics" in red underneath. Below that is the text "Full Function, Faster" in blue. ### DEVICE INFORMATIC ### A. Intended Use The EVOLUTION® NitrX™ Medial-Pivot Knee is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis - 2. Inflammatory degenerative joint disease, including rheumatoid arthritis; - 3. Correction of functional deformity 4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only. # B. Device Description The EVOLUTION® NitrX™ Medial-Pivot Knee is a line extension of the EVOLUTION® MP Total Knee System product line. The device is intended to be used as a medial pivot option in total knee arthroplasty (TKA). The subject device is composed of a femoral component to replace the distal surface of the patient's natural femur and a tibial baseplate component to replace the proximal surface of the patient's natural tibia. The design features are summarized below: - . Manufactured from Cobalt Chrome Alloy - Coated with Titanium Niobium Nitride ● - Sizes 1-8, left and right ● # C. Substantial Equivalence Information The design features and materials of the subject devices are substantially equivalent to those of the predicate/reference devices. The indications for use are identical to the predicate device. The fundamental scientific technology of the modified devices has not changed relative to the predicate device. The safety and effectiveness of the subject devices are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image is a logo for MicroPort Orthopedics. The logo features a blue square with rounded corners on the left side, inside of which is a white circle with a red star in the center. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red below it. Below that is the text "Full Function, Faster" in blue. ## D. Nonclinical Testing Nonclinical testing performed on the subject devices included: - Biocompatibility evaluation/testing - . Tibial baseplate component fatigue testing - Wear analysis (Mode 1 and aggressive Mode 3) - Morphological analysis ● - . Metal ion analysis Additionally, nonclinical predicate test results were used to support the subject due to equivalencies between devices. Predicate testing included: - Range of motion analysis - Stability/Constraint - Contact area/stress ● - MR Assessments- Field Interactions, Torque, Displacement, RF Heating ● - Gravimetric Analysis ● - Bioburden Testing # E. Clinical Testing Clinical data was not provided for the subject devices. # F. Conclusion The indications for use and fundamental scientific technology of the subject devices are identical to the predicate devices. Design features, materials information, predicate testing and analysis data provided in this premarket notification adequately support the substantial equivalence of EVOLUTION® NitrX™ Medial-Pivot Knee.